Aurobindo Pharma

I am holding Aurobindo from very low level. Multi-Bagger now. I clearly say management is still a suspect due to political affiliations (if not fraud) and still need to watch out for. I am alert and ready to bolt at the slightest pretext. If management does not screw up then the business should do well for next 4-5 years. They have many ANDAs in pipeline and that should help. The stock should compound froom here on for some more time. But in the next 2 years we will have to take a call on sell when the stock is fully priced and factors in all good things.

Anyone having insight into the recent slump?
The stock was holding up pretty well despite gloomy market but slided around 25% in a span of 6-8 trading sessions!
Their pipeline still looks decent and Q3 results didn’t disappoint either.

How much revenue Aurobindo can expect from Rosuvastatin 180 day exclusivity.

http://www.aurobindo.com/docs/press-room/company-news/2016-2017/pr-usfda-fa-rosuvastatin-calcium-tablets.pdf

We have to be very careful with the words used by the companies. The wordings in Aurobindo disclosure are is eligible for. The words does not mean shared exclusivity has been granted by US FDA as far as I understood.

Critical comments invited.

Another important word in the press release is shared exclusivity. What does it mean?

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The below link might be the reason of the word in the Press Release
eligible
US FDA happened to approve the ANDA filings of 3 pharmacos (Aurobindo Pharma, Glenmark Pharmaceutical and Sun Pharmaceuticals) for the bio-equivalence CRESTOR drug manufactured by IPR Pharmaceuticals Inc.

Though all 3 pharmacos have received the ANDA approval, Aurobindo Pharma was the generics manufacturer (Generic drugs approved by the FDA have the same quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs) eligible for the 180 days exclusivity. This was because Aurobindo was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification

shared exclusivity

Watson Pharmaceuticals Inc. of Parsippany, New Jersey was the first company to receive the approval to market generic rosuvastatin calcium. A settlement in a patent infringement suit gave the Watson the sole rights to start selling its version in early May, 67 days before the exclusivity ended on 8 July.

Auro AR: Key points

vertically integrated its APIs with finished dosages for 75% of its formulation products

to commission three new manufacturing facilities in India

making investments in dermatology and inhaler products at a new facility at Raleigh, NC, USA

The oral, solid dose formulations sections of oncology & hormone manufacturing facility has been completed and commissioned.

The injectable areas of the oncology facility are expected to be commissioned in the later part of 2016.

A new block to manufacture oncology API is being added. The manufacturing facility is expected to be operational in 2017-18.

plans are to complete the product filings for dermatology and inhalers by early 2018

Speciality injection products: to file 1st product in 17-18. to launch 4 identified products; market size of around USD 3 billion.

OTC products seeing significant traction in US

Thru Natrol, have exposure to 38b$ nutraceutical industry.

Single minded focus to develop differentiated, difficult to develop, complex products.

In the last 1 yr, US FDA approval activity has picked up significantly.

at the current approval rate, annualized approvals are likely to be 700 versus historical approvals in the 400-500 range.

The higher approval rates are likely to benefit the large pharmaceuticals companies that have strong
US pipeline.

Germany’s pharma spends constitutes more than 25% of Euro pharma market.

India’s pharma industry likely to grow at 14%. patents of at least a dozen blockbuster drugs in the US expire in the next 3 years

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Overall, This year’s AR was a fascinating read! Would highly recommended reading this to anyone interested in gaining some insights into the Pharma generics industry.

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Aurobindo Pharma gets FDA nod for Linezolid Injection

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Aurobindo Pharma Ltd has announced the following Unaudited Standalone results for the quarter ended June 30, 2016:

The Company has posted a net profit of Rs. 3910.30 million for the quarter ended June 30, 2016 as compared to Rs. 4079.50 million for the quarter ended June 30, 2015. Total Income has increased from Rs. 22443.70 million for the quarter ended June 30, 2015 to Rs. 23995.40 million for the quarter ended June 30, 2016.

The Consolidated Results are as follows:

The Unaudited Consolidated results for the Quarter ended June 30, 2016

The Group has posted a net profit after taxes, minority interest and share of profit of joint ventures of Rs. 5849.60 million for the quarter ended June 30, 2016 as compared to Rs. 4724.50 million for the quarter ended June 30, 2015. Total Income has increased from Rs. 33283.00 million for the quarter ended June 30, 2015 to Rs. 37417.90 million for the quarter ended June 30, 2016.

http://corporates.bseindia.com/xml-data/corpfiling/AttachLive/43474F98_36B6_419D_B864_059565D391B7_193110.pdf

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Excellent set of numbers from Aurobindo. Topline grew by 13%(slightly below expectation), EBITDA margin improved by 175bps, PAT margin by 138bps.

Disc: Invested

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Aurobindo Pharma Q1 net profit rises 24% to Rs585 crore

‘Big Bull’ Rakesh Jhunjhunwala Questions Aurobindo Pharma’s Management

http://www.aurobindo.com/docs/annual-reports/aurobindo-pharma-ltd-q1fy17-earnings-presentation-aug-2016.pdf

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Aurobindo Pharma: Margin improvement continues; US growth to excel further– Detailed Report Motilal Oswal

file:///C:/Users/Swapnil/Downloads/20160824_Aurobindo-Pharma-Limited_204_QuarterUpdate.pdf

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Improved margins, better sales mix make Aurobindo Pharma stock analysts’ top pick

Read more at:
http://economictimes.indiatimes.com/articleshow/53991257.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

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US FDA completes Aurobindo’s Unit 4 audit; to help boost US biz

Read more at: http://www.moneycontrol.com/news/business/us-fda-completes-aurobindos-unit-4-audit-to-help-boost-us-biz_7475641.html?utm_source=ref_article

BoAML retains buy on Aurobindo, sees 23% EPS CAGR over FY16-18

Aurobindo Pharma receives USFDA tentative approval for Dolutegravir

Aurobindo Pharma to launch HIV drug in Africa this year, gets tentative FDA nod
Read more at http://rtn.asia/d-n/23059/aurobindo-pharma-launch-hiv-drug-africa-year-gets-tentative-fda-nod#iIbwBEvP0lkw3SXF.99

Three sustain burns in blast at Aurobindo Pharma in Srikakulam

http://www.newindianexpress.com/states/andhra-pradesh/2016/dec/13/three-sustain-burns-in-blast-at-aurobindo-pharma-in-srikakulam-1548494.html